BREATHNINE SYRUP 2MG5ML

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

SALBUTAMOL SULPHATE

Available from:

SM PHARMACEUTICALS SDN. BHD.

INN (International Name):

SALBUTAMOL SULPHATE

Units in package:

100ml mL; 60ml mL

Manufactured by:

SM PHARMACEUTICALS SDN. BHD.

Patient Information leaflet

PLEASE REFER TO E12

Summary of Product characteristics

Package Insert
Page 1 of 5
SM PHARMACEUTICALS SDN. BHD.
BREATHNINE (SALBUTAMOL SULPHATE) SYRUP 2 MG / 5 ML
DESCRIPTION:
A clear, red coloured liquid with sweet taste and raspberry flavour.
COMPOSITION:
Salbutamol Sulphate equivalent to 2mg / 5ml Salbutamol.
ACTIONS AND MODE OR MECHANISMS OF ACTION:
A direct-acting sympathomimetic amine. Acts relatively selectively on
beta 2 adrenergic
receptors in the lungs to relax bronchiol smooth muscle, thereby
relieving bronchospasm
and reducing airway resistance. Also relaxes smooth muscle of the
uterus and vascular
supply to the skeletal muscle. These actions are believed to result
from increased
production of cyclic adenosine 3'5' monophosphate (cylic 3'5' -AMP)
caused by activation
of the enzyme adenyl cyclase.
PHARMACOLOGY
(SUMMARY
OF
PHARMACODYNAMICS
AND
PHARMACOKINETICS):
Absorption - Well absorbed from the gastrointestinal tract.
Metabolism - Hepatic, primarily to salbutamol 4'-0 sulfate which has
little or no beta-
adrenergic blocking activity..
Half life - (plasma) 2.7 to 5 hours.
Onset of action - within 30 minutes
Time to peak plasma concentration - within 2 to 3 hours following a 6
mg of tritiated
salbutamol sulphate.
Time to peak effect – 2 to 3 hours.
Duration of action – 6 hours or longer.
Excretion - Renal; approximately 76% of oral dose excreted over 3 days
in the urine, the
majority of dose being excreted within the first 24 hours, consisting
of 60% as metabolites.
Faecal; About 4% of oral dose may be excreted in the faeces.
INDICATIONS:
a. Relief of broncial asthma
b. Chronic bronchitis
c. Emphysema
d. Acute dyspnea
CONTRAINDICATIONS:
Use of this medication should be carefully considered when the
following medical
problems exist (reasons given where appropriate).
Cardiovascular disorders, including coronary insufficiency and
hypertension.
Package Insert
Page 2 of 5
Diabetes mellitus, Enlarged prostate, Hyperthyroidism.
SIDE EFFECTS / ADVERSE REACTIONS:
Fine
tremor
(usually
hands),
nervous
tension,
headache,
peripheral
vasodilation,
tachycardia (seldom